Location: San Diego, CA
Company: Mapp Biopharmaceutical
and in support of biodefense programs. The Early Research and Development Group (ERDG) and the Advanced Research and Development Group (ARDG) at Mapp Biomedical are responsible for the execution of high-quality Research and Development activities to ensure the achievement of a robust portfolio through CMC, Nonclinical, Regulatory, Project Management, and Clinical activities consistent with Mapp's product development objectives.
The Director of Quality Assurance - Gx P Analytical is an individual contributor who is a strategic thinking employee functioning as a key member of the Quality Assurance team who also partners with the CMC, Nonclinical, and Clinical development functions to ensure
data integrity and phase-appropriate compliance. Additionally, the Director of Quality Assurance - Gx P Analytical partners with Principal Investigators and the program teams to deliver on Mapp's portfolio.
Basic Qualifications BS/BA Degree in a related Science; MS Degree in related Science preferred 10+ Years of a combination of development experience in regulated medical roles, preferably within a Biologics/m Ab Product Development environment A significant amount of this time in a position that led or supported analytical and quality control operations for Drug Substance and Drug Product development and manufacturing Experience in a QA-Gx P role or a role that interacted with Quality
Assurance A solid background in analytical technologies and troubleshooting for large molecule products (preferably monoclonal antibodies) Strong background and in-depth knowledge in analytical chemistry across a wide range of technologies Demonstrated proficiency in method qualification, validation, stability programs and specifications setting and comprehensive understanding and significant experience in executing phase-appropriate qualification/validation strategies Excellent knowledge of c GMPs or equivalent regulations, e.
g. ICH, and the ability to interpret and relate Quality standards for implementation and review Experience in working with external parties (CDMOs, Contract Labs) Possesses the knowledge to act as a SME on any QA-Gx P data integrity issues Knowledge of drug development regulations such as the GCPs, GMPs and GLPs Willingness to travel required (up to 25% domestic and international) Previous technical CMC experience with large molecule (preferably monoclonal antibody) Drug Substance and/or Drug Product development/commercialization Previous experience with auditing biological and parenteral manufacturing facilities, laboratories that perform regulated activities, and/or clinical sites Experience overseeing Gx Ps (as a Sponsor) at third-party locations in a small or mid-sized Biotechnology company Preferred Qualifications MS Degree in related Science preferred Experience across all phases of biologic drug development (Clinical phases 1 thru 4 of drug development) preferred Experience in a technical or QA role for the oversight or execution of monoclonal antibody Drug Substance and Drug Product manufacture Experience working virtual preferred Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job.
Mapp's anticipated pay scale for this position is $130,000 to $250,000 plus any applicable bonuses.
The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the candidate's level of education, and type and length of experience within the job and/or within the industry. Medical, dental, and vision insurance benefits are available to eligible employees and their families. Mapp also provides basic life insurance, short and long term disability, and a 401K plan that includes Company contributions to eligible employees. Full-time employees will be provided 7 days of sick time, 14 paid holidays, and will also accrue 18 days of vacation throughout the calendar year.
If your job responsibilities allow, you may choose to work remotely. Willingness to Travel (Domestic Travel = Approximately Once per month + International Travel = Approximately Twice per year) will be required for this position. Mapp wants you to join their team and invites you to apply by submitting your information through mappbio. /jobs/. This job will remain open for twenty (20) days after being posted on Mapp's Job Openings website page (see link). No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify.
Mapp is an Equal Opportunity/Affirmative Action/Disability/Veterans Employer - Qualified applicants will receive consideration for employment without regard to race, color, religion, interaction, interactionual orientation, gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law. Job Posted by Applicant Pro
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